LVivo IQS is an AI-powered platform designed to analyze ultrasound images of the heart, specifically providing real-time quality scoring of right ventricle images from the 4-chamber apical view. This software helps clinicians by automatically detecting, measuring, and calculating important cardiac parameters and providing feedback on image quality, enhancing the reliability and interpretability of ultrasound examinations.
LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.
The LVivo IQS is an AI-based algorithm provided as a software module (API) designed to be integrated into existing ultrasound imaging devices for real-time processing of right ventricle images from 4-chamber apical views, providing automated image quality scoring.
Performance was validated using retrospective and real-time data from various ultrasound devices and cardiac pathologies, showing 77% agreement with expert sonographer tagging and high clinical interpretability with over 85% medium or better image quality scores.
No predicate devices specified
Submission
3/21/2024
FDA Approval
5/24/2024
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